Servier’s Tibsovo Receives the US FDA’s Approval for the Treatment of Myelodysplastic Syndromes (MDS)
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- The approval was based on the P-I clinical trial evaluating Tibsovo in patients (n=18) with IDH1-mutated r/r MDS. MDS is the 5th approved indication for Tibsovo, a precision medicine that targets the IDH1 mutation
- The results depicted a CR rate of 38.9%, ORR of 83.3% & a median time to CR of 1.9mos. whereas at data cutoff the median duration of CR was not reached & mOS was 35.7mos. Moreover, 6/9 patients who were RBC transfusion-dependent became independent during ≥56-day post-baseline period
- Tibsovo received BTD & Priority Review from the US FDA for IDH1-mut r/r MDS. Additionally, the US FDA also approved Abbott’s RealTime IDH1 Assay as a companion diagnostic device to select patients for Tibsovo
Ref: PRNewswire | Image: Servier
Related News:- Servier Reports the US FDA Acceptance of sNDA and Granted Priority Review of Tibsovo (ivosidenib) for R/R Myelodysplastic Syndromes
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
